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Lympholyte-H

Cedarlane Corporation · Model CL5016 · UDI-DI 00628451099482

JCF
10
510(k) clearances
293
Adverse events
4
Recalls
13
Facilities

Description

Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid

Recalls

DateFirmReason
2014-07-03Becton Dickinson & CompanyBD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
2009-12-08Sigma-Aldrich Mfg LLCInstructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
2009-12-08Sigma-Aldrich Mfg LLCInstructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
2009-09-04Sigma-Aldrich Mfg LLCSome of the product was contaminated with Pseudomonas mendocina

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.